PFE Pfizer Inc

By Jared S. Hopkins and Matt Grossman 

Pfizer Inc. said a global late-stage trial evaluating its Covid-19 vaccine is almost fully enrolled with participants, the company said, as its chief executive called for patience as researchers advance in collecting trial results.

The drugmaker hasn't yet conducted the first review of whether its experimental vaccine works safely.

Pfizer's Phase 3 trial seeking 44,000 volunteers needs fewer than 2,000 people to be fully enrolled, the company said Tuesday while announcing third-quarter earnings. The New York-based company also said that nearly 36,000 people in the trial received their second injection of either the two-dose vaccine or a placebo.

Pfizer's Covid-19 vaccine, which it is developing in partnership with Germany's BioNTech SE, is among the most advanced shots from pharmaceutical companies working to help stem the global pandemic.

"We have reached the last mile," Pfizer Chief Executive Albert Bourla said on a conference with analysts discussing earnings. "Let's all have the patience required for something so important for public health and the global economy."

Mr. Bourla reiterated the time line he laid out earlier this month for the vaccine's potential rollout. He said Pfizer could file for an emergency authorization to put the vaccine into initial public use in late November, assuming positive trial results -- suggesting shots could be made available in the U.S. before the end of the year.

He also sought to provide assurances that vaccine development won't be politicized. Mr. Bourla called the upcoming U.S. presidential election "an artificial milestone" and asked for patience as trial data is collected, analyzed and potentially filed to regulators. "This is going to be not a Republican vaccine or a Democratic vaccine. It would be a vaccine for the citizens of the world," he told investors.

He added, "I know how much stress levels are growing. I know how much a vaccine is needed for the world."

An outside panel of experts hasn't performed the first review of whether the vaccine works safely, known as an interim analysis, which was planned once 32 study participants become infected with symptomatic Covid-19, Pfizer said Tuesday. The review is performed by an outside group of experts known as the data safety monitoring committee. "We don't have the 32 events right now," Mr. Bourla said.

In an interview, Mr. Bourla said it is "extremely unlikely" any efficacy data about the vaccine would be made public before Nov. 3, partly because once the company gets the data it would take about a week to thoroughly analyze it.

In Pfizer's study, half the participants get a two-dose regimen of the vaccine three weeks apart, with the rest getting placebo shots. A week after subjects receive their second shot, researchers begin checking whether the vaccinated group develops symptoms more or less frequently than those who weren't vaccinated. The Food and Drug Administration is requiring two months of observational safety data of vaccinated study participants.

President Trump has said a Covid-19 vaccine could be available before election day. Pfizer's development time line, as well as those of the other top Covid-19 vaccine developers, make a pre-election greenlight highly unlikely.

Pfizer has already spent nearly $2 billion on its Covid vaccine program. AstraZeneca PLC, Moderna Inc. and Johnson & Johnson also have vaccines in advanced development.

Mr. Bourla said that Pfizer, which is ramping up manufacturing capabilities, will be able to meet its commitment to provide 100 million doses in the U.S. by March, and to deliver about 40 million by the end of this year.

He also said the company plans to provide the Covid-19 vaccine to developing and low-income countries, such as some in Africa, on a "not for profit" basis. The company's price in the U.S. has tracked to about $20 a dose, although the government purchased the initial doses and plans to provide them to people free of charge.

Sales for the vaccine are estimated at $3.5 billion next year before steadying at $1.4 billion annually, according to analysts at SVB Leerink LLC. Revenue from the vaccine would be included in 2021 guidance announced during fourth-quarter earnings, Chief Financial Officer Frank D'Amelio said in an interview.

Pfizer recorded third-quarter sales of $12.13 billion, compared with $12.68 billion in the same three-month period last year. Analysts surveyed by FactSet had forecast $12.31 billion of sales

The company's biopharma revenue grew by 3% to $10.22 billion as sales expanded for drugs such as blood thinner Eliquis, rare-disease drug Vyndaqel and arthritis treatment Xeljanz. Revenue from the company's Upjohn segment, which focuses on off-patent and generic drugs, declined by 18% to $1.92 billion.

Pfizer plans to spin off Upjohn in a combination with U.K.-based Mylan NV that will be called Viatris. In September, Pfizer and Mylan won approval from the European Commission for the deal, which is expected to close in the fourth quarter.

Pfizer said the pandemic dragged down its third-quarter revenue by approximately $500 million, or 4%, as it disrupted demand for some products in China and scrambled U.S. health-care visits that aren't related to the viral disease. Reduced doctor visits have thrown off prescribing patterns for some products, according to the company.

Pfizer's profit in the third quarter was 39 cents a share, compared with $1.36 a share in last year's third quarter. On an adjusted basis, its profit was 72 cents a share. Analysts had anticipated an adjusted profit of 70 cents a share.

The company said it expects to report full-year revenue between $48.8 billion and $49.5 billion, and an adjusted profit of $2.88 to $2.93 a share. The guidance doesn't assume revenue contributions from its Covid-19 vaccine.

Write to Jared S. Hopkins at jared.hopkins@wsj.com and Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

October 27, 2020 15:59 ET (19:59 GMT)

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